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11. What is valid ICSR?

11. What is valid ICSR?

Sources of Adverse event reporting: Theinformation about adverse event collected from different sources. Below are types of reports – 

  1. Spontaneous / Voluntary reports
  2. Clinical trials and Post marketing studies
  3. Regulatory reports
  4. License partner reports
  5. Literature reports

Once report is received it is checked for following four parameters

to consider it as a valid case;

1. Identifiable patient

2. Identifiable reporter

3. Suspect product

4. Adverse event or fatal outcome

Criteria for Assessing Patient and Reporter Identifiability:

  • Patient and reporter identifiability is important to avoid case duplication, detect fraud, and facilitate follow-up of appropriate cases. 
  • The term identifiable in this context refers to the verification of the existence of a patient and a reporter.
  • Local data privacy laws regarding patient and reporter identifiability might apply.
  • One or more of the following should automatically qualify a patient as identifiable: age (or age category, e.g., adolescent, adult, elderly), gender, initials, date of birth, name, or patient identification number. 
  • The reporter should have first hand knowledge on event experience.
  • Following one or more criteria qualify to consider reporter as identifiable: Initials, name of a person or relationship to the patient (e.g. parent), Name of an institution, complete mailing address, professional qualification (e.g. MD, Dr.), reporter Occupation, Address, Phone Number, Fax Number, Email Address, and Reporter type.
  • In addition, in the event of second-hand reports, every reasonable effort should be made to verify the existence of an identifiable patient and reporter.
  • All parties supplying case information or approached for case information should be identifiable: not only the initial reporter (the initial contact for the case), but also others supplying information.

Case to be considered as invalid for below criteria: 

  • A report referring to a definite number of patients should not be regarded as a case until the minimum four criteria for case reporting are met. For example, “Two patients experienced…” or “ a few patients experienced” should be followed up for patient-identifiable information before regulatory reporting.
  • Medical inquiries about AEs with no patient
  • Non-human subject (pet)
  • A reporter who refuses to give his/her name or address, professional qualifications and/or relationship to the patient

Suspect product:

A suspect product is one which is thought to have caused the adverse drug reactions or an side effect to patient. 

If the case received by any marketing holder then it is the company responsibility to check if the product which caused adverse event belong to their company to not. 

Below criteria are used: 

  • Product registered status, marketing status, in-licensed, or co- promoted by company or MAH (globally or locally)
  • If only generic formulation is mentioned in report without manufacturer name then marketing status of a generic formulation will be checked. 
  • For clinical trial cases if patient enrolled in trial and receiving study medication/blinded product/placebo then it is considered as valid report.

Criteria for not a valid suspect drug:

  • A generic formulation of a company product (manufacturer known)
  • No event reported to company drug (in this situation report will be sent to marketing holder of suspect product)

Reportable Adverse Event

For an event to be considered reportable to regulatory authority it should meet all of the following criteria.

  1. An event must have occurred after receiving product. Typical events are:
    • A specific symptom or diagnosis laboratory finding, Drug/food interaction, lack of efficacy or lack of expected therapeutic effect (as defined in the product label), medication errors.
    • Pregnancy
    • Overdose
    • Abuse, accidental administration
    • Disease aggravation.
    • An inaccuracy in the labelling, instructions for use and/or in promotional materials. Inaccuracies include omissions and deficiencies.
    • The discovery of a serious public health threat
    • Medication use error
  2. An identified medical device is associated with the event.
  3. The event led to one of the following outcomes:
  • The death of a patient, user, or other person
  • Serious injury to a patient, user, or other person. Serious injury being a life threatening illness or injury; permanent impairment of a body function or permanent damage to a body structure; a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
  • No death or serious injury occurred but the event might lead to death or serious injury of a patient, user, or other person if the event recurs

Non-reportable Events

The following events are not considered to be reportable events.

  • Event same as product indication without change in severity / progression
  • Irreparable damage and not specified further.
  • Patient hospitalized – with no symptoms or diagnosis that led to the hospitalization (follow up to be performed to get more information on cause)
  • Rehabilitation therapy
  • Planned surgeries
  • Treatment non compliance
  • Reported event same as medical history without change in severity / progression
  • Queries on product
  • If adverse event is prior to suspect product date
  • Deficiency of a new device found by the user prior to its use. The deficiency being one that would always be detected by the user and where no serious injury has occurred are not reportable events.

If case meets above four criteria then that report is considered as valid report

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